AI Article Synopsis
- The 2023 updates to USP chapter <800> and major revisions to USP <795> have made previous studies for extended beyond use dates (BUD) inadequate, prompting a need for new evidence in compounding.
- Researchers conducted stability indicating testing and antimicrobial effectiveness testing (AET) on 12 combinations of topical and transdermal hormone preparations using two cream vehicles, Phytobase™ and HRT Heavy™, resulting in a total of 24 tested formulas.
- The study evaluates the appropriateness of Phytobase™ and HRT Heavy™ for compounded hormone therapy (CHT) and examines their compatibility with various hormones like estriol, estradiol, testosterone, progesterone, and dehydroepiandroster
Article Abstract
The release of USP chapter <800> Hazardous Drugs -Handling in Healthcare Settings and the major revisions to USP <795> Pharmaceutical Compounding -Nonsterile Preparations in 2023 rendered many studies previously used to justify extended beyond use date (BUD) no longer sufficient. To provide compounders with high quality evidence to support physical, chemical, and microbial stability of hormone preparations in two aqueous cream vehicles, Phytobase™ and HRT Heavy™, we set out to perform stability indicating testing and antimicrobial effectiveness testing (AET) per USP <51> on 12 different combinations bracketed in high and low concentrations (for a total of 24 tested formulas) of common topical and transdermal hormones. In this study we discuss the suitability of Phytobase™ and HRT Heavy™ for compounded hormone therapy (CHT) and the compatibility of these vehicles with hormones including estriol, estradiol, testosterone, progesterone, and dehydroepiandrosterone both alone and in combination.
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